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U.S. regulators on Wednesday authorized the country’s fourth coronavirus vaccine, a vaccine developed by Novavax, a Maryland biotechnology company that has been a delay in the vaccine’s career.
How Novavax differs from other coronavirus vaccines
For a relatively small niche of people who want to get vaccinated but can’t or don’t want to get the existing vaccines, Wednesday’s decision by the Food and Drug Administration has been eagerly awaited. Some people are allergic to an ingredient in messenger RNA vaccines or simply prefer the more traditional technology to the Novavax vaccine core, which is the first protein-based vaccine in the United States.
However, the late addition of the Novavax vaccine to the medical arsenal is not expected to have a significant impact on the coronavirus trajectory. Two-thirds of Americans have received at least their initial series of vaccines and vaccine doses from other companies are available in abundance.
The authorization covers the use of the vaccine as an initial set of two injections in adults. The company plans to apply for permission for a reinforcement and for the younger ones.
The Novavax Two-Regime Vaccine uses a technology that is used to make flu and shingles vaccines. The vaccines from Moderna and Pfizer and their German partner, BioNTech, use messenger RNA technology to instruct the body’s cells to build a protein. A Johnson & Johnson vaccine uses a harmless cold virus.
An advisory committee from the Centers for Disease Control and Prevention that votes on the vaccine recommendation is scheduled to meet Tuesday.
The federal government has secured 3.2 million doses of the Novavax vaccine, which will be available “in the coming weeks,” after the company completes quality testing, according to a statement from the Department of Health and Human Services on Monday.
Wednesday’s FDA decision “underscores the critical need to provide another vaccine option for the U.S. population as long as the pandemic continues,” Stanley C. Erck, Novavax’s chief executive, said in a statement.
In the long run, Novavax executives believe their vaccine may be key to managing the virus as a seasonal booster. The FDA has already instructed companies to renew their shots to increase the fall, and Novavax scientists are working on a renewed feature aimed at the BA.4 and BA.5 subvariants that are circulating.
Initial data is expected on the new Novavax booster variant targeting the BA.4 and BA.5 sub-variants in late summer or fall, and the company expects to be able to provide an updated booster injection during the last quarter.
Novavax executives recently presented data that intrigued some FDA advisors, suggesting that the original formulation of the vaccine may well withstand difficult variants in circulation.
“The Novavax data was quite significant,” said Wayne A. Marasco, an FDA advisor and professor of cancer immunology and virology at the Dana-Farber Cancer Institute, noting that it appeared to offer good protection until and all against the difficult variant omicron BA.5. “I wonder if we are not witnessing some of the limitations that may exist [of] mRNA vaccines. Yes, they were the first to walk out the door. But they don’t seem to have that breadth of protection. “
The Novavax vaccine is being manufactured by the Serum Institute of India, and a Novavax spokeswoman confirmed that the doses had been shipped to the United States, arriving on 6 July.
Novavax’s slowest release reflects technology at the core of its vaccine, which requires more time to produce, and the setbacks of a small business working furiously to launch its first vaccine on a large scale and meet stringent standards US regulators.
Messenger RNA vaccines, which were authorized in late 2020, tell the body’s cells to make coronavirus spikes that splatter the outside of the virus. Novavax has to make these spike proteins in a laboratory and purify them, a process that takes longer.
But Novavax also faced significant delays due to manufacturing issues during vaccine development. Unlike other vaccines that were authorized a few hours or days after FDA advisers voted for them, it has taken more than a month for the official signature. In briefing documents in early June, FDA officials noted that “testing and submission of manufacturing and product information … were still in progress at the time of this review.”
The government’s purchase of 3.2 million doses leverages existing agreements between the company and the government, including a $ 1.6 billion contract to support the development and manufacture of Novavax vaccines and the purchase of 100 million doses .